Horizontal Recommendation for Use sheets (RfUs) of the ... · 00.124 02 Directive 89/686/EEC Boil-and-bite mouth guards 03/12/05 30/06/05 00.125 05 Directive 89/686/EEC, Article 11.A

Horizontal Recommendation for Use sheets (RfUs)of the European Coordination of Notified Bodies in the field of PPE

Status: November 2017 1

Number of RfU

Version Reference Keywords Approved by Horizontal Committee

Approved by PPE Expert

Group

00.001 01 Directive 89/686/EEC, Article: 12

Declaration of conformity 24/06/94 01/07/96

00.002 03 Directive 89/686/EEC, Annex: III, 2

Technical file, control and test facilities 31/05/96 03/06/97

00.003 01 Directive 89/686/EEC, Article: 7

EC type examination certificate, withdrawal

24/06/94 01/07/96

00.005 04 Directive 89/686/EEC, Article: 10.2

Type examination certificate 24/01/13 01/10/15

00.006 04 Sub-contracting, accreditation, acceptance of test results, competence of laboratories

31/05/96 03/06/97

00.007 04 Directive 89/686/EEC, Article: 10.5, 85/374/EEC

Retention, technical file, samples, liability 24/01/13 01/10/15

00.008 02 Directive 89/686/EEC, Annex: II, 1.4

User information, availability 24/06/94 01/07/96

00.010 01 Directive 89/686/EEC, Annex : II, 1.4

User information, conformity assessment 24/06/94 01/07/96

00.011 01 Directive 89/686/EEC, Annex III

Technical file 24/06/94 01/07/96

00.012 04 Directive 89/686/EEC, Article 10.2

EC type examination, application 31/05/96 03/06/97

00.013 03 Directive 89/686/EEC, Article 10.5, 10.6

Type examination certificate, withdrawal, extension, refusal

31/05/96 01/07/96

00.014 02 Certification, modified model 24/06/94 01/07/96 00.015 01 Directive 89/686/EEC,

Article 8.2 Limited series, individual items of PPE 24/06/94 01/07/96

00.016 03 Directive 89/686/EEC, Article 10.4

EC type examination procedure, harmonised standards

31/05/96 03/06/97

00.017 01 Test reports 24/06/94 01/07/96 00.018 03 Directive 89/686/EEC,

Article 10.4 Standards, deficiencies 31/05/96 03/06/97

00.019 01 Directive 89/686/EEC, Annex II, 1.4

User information 24/06/94 01/07/96

00.020 01 Testing of materials 24/06/94 01/07/96 00.021 01 Type examination certificate,

modification of products 24/06/94 01/07/96

00.022 01 Identification of test samples 24/06/94 01/07/96 00.023 02 Directive 89/686/EEC,

Article 11 A.1 Quality control, manufacturer 31/05/96 01/07/96

00.024 02 Directive 89/686/EEC, Article 11 A.2

Quality control, checks 31/05/96 01/07/96


Quality control, application of CE marking

31/05/96 01/07/96


11A checks, time interval, random 22/11/13 01/10/15

00.029 01 CE marking, categories 24/06/94 20/05/95 00.030 04 Directive 89/686/EEC,

Article 11 A.2 Necessary checks 27/05/98 20/04/98

00.031 02 Directive 89/686/EEC, Article 11 B

Article 11B, withdrawal of certificates 22/11/13 01/10/15

00.032 01 Manufacturer, authorized representative 02/06/95 01/07/96 00.034 02 Directive 89/686/EEC,

Article 10 Type examination: contents of technical file, technical documentation

01/06/95 18/11/97

00.036 03 Directive 89/686/EEC, Annex II, 1.4 (e)

Period of obsolescence 24/01/13 01/10/15

Horizontal Recommendation for Use sheets (RfUs) of the European Coordination of Notified Bodies in the field of PPE


Number of RfU



Group

00.038 03 Directive 89/686/EEC Components from different manufacturers

27/05/98 20/04/98

00.046 04 Directive 89/686/EEC Marking, standard reference, testing according to prEN

26/05/99 21/06/99

00.048 03 Directive 89/686/EEC, Article 11 A

Sampling 11 A procedures 04/06/97 20/04/98

00.051 04 Directive 89/686/EEC, Article II, 1.4

Use of pictograms 23/02/00 15/01/02

00.052 03 Test reports, designation of materials 04/06/97 20/04/98 00.058 03 Test reports, materials 04/06/97 20/04/98 00.061 03 Slip resistance, type examination

certificate 18/11/97

00.064 03 Directive 89/686/EEC Type examination for category I PPE 04/06/97 20/04/98 00.068 05 Directive 89/686/EEC Revision of standard, validity, EC type

examination certificate 26/05/99 21/06/99

00.074 04 Directive 89/686/EEC, Article 11 A

Change of certificate 04/06/97 20/04/98

00.075 04 Directive 89/686/EEC, Article 10.2, 11 A, 11 B

Distribution, type examination certificate 04/06/97 20/04/98

00.077 07 Directive 89/686/EEC, Annex II, 1.4

Information to users 05/05/06 31/07/06

00.080 02 Directive 89/686/EEC, Article 10

Production Plant 18/11/97

00.081 03 Directive 89/686/EEC, Article 1.2 (c)

Interchangeable components, EC type examination

27/05/98 21/06/99

00.086 08 Directive 89/686/EEC, Article 11 B

Composition of audit team; competency of auditors; knowledge of auditors

22/11/13 01/10/15

00.087 06 Quality assurance system 22/11/13 01/10/15 00.088 04 Directive 89/686/EEC,

Article 11.B (2) Quality Assurance System, Supervision, Frequency of Audits

05/01/98 20/04/98

00.089 03 Directive 89/686/EEC, Article 11.B (c)

ISO 9001/2/3:1994 05/01/98 20/04/98

00.090 04 Directive 89/686/EEC, Article 11.B (b) 11.A.3

22/11/13 01/10/15

00.092 02 Directive 89/686/EEC, Annex II, Article 1.4 (i)

Notified body reference, information supplied by the manufacturer

26/05/99 21/06/99

00.093 02 Directive 89/686/EEC Element, CE marking 27/05/98 21/06/99 00.094 02 Directive 89/686/EEC Harmonised standards, essential

requirements, EC type examination 27/05/98 21/06/99

00.095 02 Directive 89/686/EEC, Article 10, 4 (b)

Technical file 26/05/99 29/11/99

00.096 06 Directive 89/686/EEC, Annex II, 1.2.1.1

Innocuousness of PPE 04/07/01 15/01/02


Conformity to standard 23/02/00 15/01/02

00.099 02 Directive 89/686/EEC CE marking, separate items of PPE, technical file

27/05/99 29/11/99

00.104 02 Directive 89/686/EEC, Article 8.4 a

Category; certification 23/02/00 15/01/02

00.106 04 Directive 89/686/EEC, Article 11.B.2

Re-assessment of approved quality system

02/12/04 30/06/05

00.107 02 Directive 89/686/EEC, Article 11.A.3

Sample selection 27/10/00 15/01/02

00.109 03 Directive 89/686/EEC, Article 11.A

11.A test clauses 05/05/06 31/07/06

Horizontal Recommendation for Use sheets (RfUs) of the European Coordination of Notified Bodies in the field of PPE


Number of RfU



Group

00.113 03 Directive 89/686/EEC, Annex III, Article 10

Test and Inspection of Production 12/12/02 11/06/03

00.114 03 Directive 89/686/EEC, Article 8.4, 11.A, 11.B

Manufacture 05/09/02 11/06/03

00.117 02 Directive 89/686/EEC, Annex II, 1.2.1.1

Information supplied by the manufacturer; sensitising or allergenic substances

05/09/02 11/06/03


Categorisation; welding 05/09/02 11/06/03


Category III product 06/09/02 11/06/03

00.122 03 Directive 89/686/EEC, Article 10 and 11 A

Retention of representative samples 03/12/04 30/06/05

00.123 06 Directive 89/686/EEC, Article 10 and 11 A

External testing 05/11/15 04/04/16

00.124 02 Directive 89/686/EEC Boil-and-bite mouth guards 03/12/05 30/06/05 00.125 05 Directive 89/686/EEC,

Article 11.A Uniformity of production; Article 11.A 24/06/09 20/04/11

00.126 02 EN 17025, Clause 5.10.3.1 c.)

Uncertainty of measurement 26/08/05 31/07/06

00.127 03 Dedicated test method standards 24/01/13 01/10/15 00.128 02 Directive 89/686/EEC,

Article 1, 2 c.) Interchangeable components of breathing apparatus

05/05/06 31/07/06

00.129 02 Directive 89/686/EEC, Article 1, 2 c.)

Interchangeable components of breathing apparatus

05/05/06 31/07/06

00.130 02 Directive 89/686/EEC Own-brand certificates 05/05/06 31/07/06 00.131 02 Directive 89/686/EEC Standard template for report content

covering annual assessment process 09/02/07 15/07/08

00.132 02 Directive 89/686/EEC Sizing 09/02/07 15/07/08 00.133 02 Directive 89/686/EEC,

Article 10 / 11 Traceability of article 10 technical file documents

09/02/07 15/07/08

00.134 02 Directive 89/686/EEC, Article 10, 11

Article 11 assessment, EC type examination certificate

09/02/07 15/07/08

00.135 04 11B minimum requirements 18/10/09 20/04/11 00.136 06 Directive 89/686/EEC,

Article 10 EC type examination certificates; validity 14/11/14 01/10/15

00.137 03 Article 11 A.2, RfU sheet 125, 2B(iii) and 2B(iv)

Failure of 11A samples 31/08/09 20/04/11


EC type-examination, certificate format 12/05/11 15/05/12

00.139 02 Directive 89/686/EEC Marking, standard number 19/03/10 20/04/11 00.140 02 Product marking; reference to standards 19/03/10 20/04/11 00.141 02 Directive 89/686/EEC,

Annex 2, 1.4 Information supplied by the manufacturer, address of manufacturer

19/03/10 20/04/11


01/03/12 30/08/12

00.144 00 Instructions for use 22/11/13 01/10/15 00.145 00 89/686/EEC, Article

10 / Article 11A / 11B Article 11A, 11B, non-conform product, unsafe design

22/11/13 01/10/15

00.146 01 89/686/EEC, Article 11A.2, RfU sheet 125, 2B(iii) and 2B(iv)

11A samples and process / production dormant

24/01/13 01/10/15

00.147 00 89/686/EEC, Article 11A.3

11A samples / frequency of specific tests 14/11/14 01/10/15

(1) Essential safety requirement (3) N° of CEN/TC (Secretary & Chairman) (5) To be specified (2) HC = horizontal committee (4) EEC Standing Committee 89/392

CO-ORDINATION OF NOTIFIED BODIES

PPE-Directive 89/686/EEC + amendments

RECOMMENDATION FOR USE

CNB/P/00.001 Revision 01 Language : E

Number of pages : 1 Date : 15/07/96 Approval by : Approved on :

Origin : Horizontal Committee Vertical Group ....................... Horizontal Committee ........... Standing Committee .............

....... ....... 24/06/94 ....... 01/07/96

Question related to : Directive 89/686/EEC EN/prEN : Other : Annex : Article : 12

Clause :

Key words : declaration of conformity

Question : Which purpose does the declaration of conformity of the manufacturer serve? Is it to be presented with each delivery of a PPE?

Solution : The declaration of conformity has to be drawn up by the manufacturer to certify that the PPE placed on the market is in conformity with the directive; it is the basis for CE marking. The general opinion is that the declaration of conformity is to be issued by the manufacturer only once and has to be kept with the documentation of the manufacturer. This documentation has to be presented to the authorities on request.

Sent for information to : members of the VG other(s) VG HC (2) TC (3) SC (4) other (5)








....... ....... 31/05/96 ....... 03/06/97

Question related to : Directive 89/686/EEC EN/prEN : Other : Annex : III, 2 Article :

Clause :

Key words : technical file, control and test facilities

Question : Which minimal requirements are to be established for the control and test equipment of the manufacturer? Some notified bodies consider the verification of the manufacturer's control and test equipment a part of the type examination, others argue that this is not necessary, since article 10.4 (a) of the directive refers to the manufacturer's technical file, which according to annex III does not include the description of the control and test facilities.

Solution : The requirements must be seen in connection with the technical file mentioned in the directive which must describe the control and testing. The notified body must be convinced that the system described is sufficient. The verification of the control and test equipment of the manufacturer is required only in relation to quality control according to article 11 B.









....... ....... 24/06/94 ....... 01/07/96


Clause :

Key words : EC type examination certificate, withdrawal

Question : On which basis can a valid EC type examination certificate be withdrawn?

Solution : An EC type examination certificate has to be withdrawn as soon as the notified body gets knowledge of any circumstances indicating that the tested model of the PPE does no longer meet the requirements of the directive for reasons which had not been known at the time when the certificate was issued. It is recommended to note on the document that the certificate is the property of the notified body.







Number of pages : 1 Date : 24 January 2013 Approval by : Approved on :


....... ....... 24/01/2013 ....... 01/10/2015

Question related to : Directive 89/686/EEC EN/prEN : Other : Annex : Article : 10.2

Clause :

Key words : type examination certificate

Question : Is it possible to issue certificates for one and the same product to different applicants (such as manufacturer and other economic operators)?

Solution : No, there can only be one type examination certificate for each single named product. It was, however, acknowledged that the manufacturer can issue several declarations of conformity on the basis of this type examination certificate.

Sent for information to : members of the VG other(s) VG HC (2) TC (3) SC (4) other (5) (5) EU Commission






Number of pages : 1 Date : 15.12.2009 Approval by : Approved on :


....... ....... 31/05/96 ....... 03/06/97

Question related to : EN/prEN : Other : Annex : Article :

Clause : [other]

Key words : sub-contracting, accreditation, acceptance of test results, competence of laboratories

Question : Is it possible for a certification body to accept test data obtained by other than accredited laboratories? Are test reports from authorities outside the Community acceptable for the purpose of CE marking? If this is so, what is the minimum criteria to be used in judging their competency and how should they be monitored? What quality control methods should be applied to sub-contracting laboratories? Can the notified body use test reports on materials, items or components carried out by other specialised laboratories? Can the notified body use reports on tests carried out by the manufacturer or the applicant?

Solution : Under all circumstances, the notified body takes on the responsibility for test results/test reports it accepts as the basis for certification. Therefore, it should generally be recommended to use test results from accredited test laboratories only. As this will not always be possible, other sources of testing have to be used. Sub-contracting laboratories should meet the requirements according to ISO / IEC 17025, if this is not the case, the notified body has to ensure by other means that the test results are reliable. The notified body itself will have to specify the conditions for the acceptance of other test laboratories to carry out the tests. In all cases, a sub-contracting laboratory must satisfy condition (3) of Annex V of the directive. Quality control measures for sub-contracting test laboratories are important, the notified body itself is responsible for deciding how to proceed with this.









....... ....... 24/01/2013 ....... 01/10/2015

Question related to : Directive 89/686/EEC EN/prEN : Other : 85/374/EEC Annex : Article : 10.5

Clause : [other]

Key words : retention, technical file, samples, liability

Question : For how long must the EC type examination files, reference samples and tested items be stored?

Solution : The directive specifies that the technical file will have to be held at the disposal of the authorities for 10 years following the placing on the market of the PPE. In addition, the specifications of the product liability directive (85/374/EEC) should be taken into consideration. Note: The technical file should be retained by the manufacturer and the notified body. For the retention of samples see RfU 00.122.









....... ....... 24/06/94 ....... 01/07/96

Question related to : Directive 89/686/EEC EN/prEN : Other : Annex : II, 1.4 Article :

Clause :

Key words : user information, availability

Question : Questions have been raised concerning the user information to be supplied by the manufacturer, especially with regard to protective gloves. Some notified bodies seem to interpret the directive and EN 420 (protective gloves) to mean that it is sufficient, if the user information is available on request, whereas other notified bodies require the user information to be supplied with each item of PPE.

Solution : The user information should be supplied with each item of PPE (the smallest commercial package available) as it is believed that this is the spirit of the directive and provides the information where and when it is most needed.









....... ....... 24/06/94 ....... 01/07/96


Clause :

Key words : user information, conformity assessment

Question : Notified bodies that carry out certification procedures for foreign manufacturers have to decide what language version of the user information will be checked in the framework of conformity assessment.

Solution : The notified body can choose which languages it does accept for testing. Any translation is the responsibility of the manufacturer / authorized representative. It would be useful, however, to note in the test report which language version was checked.









....... ....... 24/06/94 ....... 01/07/96

Question related to : Directive 89/686/EEC EN/prEN : Other : Annex : III Article :

Clause :

Key words : technical file

Question : What does the manufacturing technical file have to contain?

Solution : A complete list of the information to be included in the technical file is laid down in annex III of the directive.









....... ....... 31/05/96 ....... 03/06/97


Clause :

Key words : EC type examination, application

Question : How can it be assured that the manufacturer has not presented the same file to two or even several notified bodies? How can it be assured that the manufacturer does not re-submit a file having been the subject of a previous EC type examination certificate refusal decision?

Solution : The manufacturer will be asked for a written confirmation that he has not submitted the same file to another notified body and that the model presented for examination has not been the subject of any previous EC type certificate refusal decision.







Number of pages : 1 Date : 15.12.2009

Approval by : Approved on :


....... ....... 31/05/96 ....... 01/07/96

Question related to : Directive 89/686/EEC EN/prEN : Other : Annex : Article : 10.5, 10.6

Clause :

Key words : type examination certificate, withdrawal, extension, refusal

Question : How should: - the EC type examination certificate - the withdrawal of an EC type examination certificate - an EC type certificate extension - an EC type examination certificate refusal be written?

Solution : The general points to be included in the documents are laid down in the directive, the notified bodies being free to decide on the form of presentation.









....... ....... 24/06/94 ....... 01/07/96


Clause : [other]

Key words : certification, modified model

Question : What is the procedure to be applied to the examination of variants of a PPE? Which criteria should be taken into account for the certificate?

Solution : The notified body is free to decide whether it will grant extensions to existing certificates or it prefers issuing a new certificate for the variant to be certified. A PPE is considered as a variant of a reference PPE only if it differs on points which have no noticeable influence on the expected performances. The variants can correspond to differences relating in particular to dimensions, shape, nature of constituent materials, colour, assembly methods, manufacturing processes etc. It will be useful to consider in the vertical groups what criteria allow for acceptance of a modified model, e.g. modifications with regard to accessories, colours, types of glues, an additional size, etc. which do not change the essential functions of protection. It is the responsibility of the notified body to evaluate for each individual case if a given PPE can effectively be considered as a variant. In case of doubt, it will carry out any check, measurement or test considered to be useful. In every case and for each of the variants, the applicant will provide the notified body with a detailed description indicating the differences in comparison with the reference model and the number of examples of these variants required for complementary checks and tests.









....... ....... 24/06/94 ....... 01/07/96


Clause :

Key words : limited series, individual items of PPE

Question : What is the EC type examination procedure for limited series and PPE manufactured singly?

Solution : In the logic of the EC directives, the model of the PPE (prototype) has to be submitted to an EC type examination before serial production starts. exceptions: pre-prototypes and research prototypes









....... ....... 31/05/96 ....... 03/06/97


Clause :

Key words : EC type examination procedure, harmonised standards

Question : What is the procedure to be applied to the EC type examination in the absence of test methods provided by the appropriate harmonized European standards?

Solution : The notified body has to decide what will be the basis for testing against the requirements of the directive. The manufacturer has to set the specification for the product and ask for certification against this specification. Under normal circumstances, the specifications of the manufacturer will remain strictly confidential. The notified body is responsible for assessing whether or not the specification meets the applicable requirements of annex II and determining whether or not the submitted PPE does comply with the requirements. It is recommended to refer to existing standards (national or ISO (international)) whenever possible. If this is not possible, the notified body should identify the objectives to be reached in testing for conformity with the requirements and specify test procedures appropriate for the EC type examination. The proposed method may be discussed with the notified bodies if this is necessary. If there is a general interest in a harmonization of the test procedure, the subject should be brought into the European standardization committee responsible.









....... ....... 24/06/94 ....... 01/07/96


Clause :

Key words : test reports

Question : presentation of test reports

Solution : It was generally agreed that no harmonized format is necessary for the presentation of test reports.









....... ....... 31/05/96 ....... 03/06/97


Clause :

Key words : standards, deficiencies

Question : What action should be taken if deficiencies or mistakes in standards are detected?

Solution : Deficiencies and mistakes in standards always have to be discussed in the relevant CEN/TC or WG. Therefore, as soon as any such mistake is recognized, the appropriate body has to be informed and asked to take action for a possible revision of the standard as soon as possible. In addition to that, the problem should be discussed within the vertical group so that a general approach to the problem is laid down and the notifed bodies can agree how to proceed with the testing before a revision of the standard is published. The relevant TC or WG should be informed of any such interim solution. If the problem is of general interest, the Horizontal Committee should be informed so that the subject can be discussed at Horizontal Committee level and, if necessary, with the relevant CEN authorities. The European Commission will receive lists of the existing Recommendation for Use sheets for information.









....... ....... 24/06/94 ....... 01/07/96


Clause :

Key words : user information

Question : On which point should the verification on the information/instruction notice provided by the certificate applicant be focused?

Solution : Within the EC type examination framework, the notified body ensures that the information/instruction notice from the manufacturer or applicant covers all the items of article 1.4 of annex II of directive 89/686/EEC modified and that it is presented in an accurate and understandable way.









....... ....... 24/06/94 ....... 01/07/96


Clause :

Key words : testing of materials

Question : Is it permissible to carry out tests on materials, parts or components identical to those comprising the PPE instead of carrying out tests on the PPE itself? If so, what are the conditions to be met for type approval and for production control?

Solution : It is possible to carry out tests on materials described in the standards with the sample taken either on the PPE itself or on a sample of the material if the manufacturer attests (in writing) that it is strictly identical to that used in the construction to the PPE and if the notified body can confirm the identity by examination of the reference PPE and the samples supplied. This procedure should be limited to a specific case as, for example, when referring to high cost PPE produced in small quantities. The applicant has to supply one example of the PPE submitted to EC type examination so that the notified body can check that the materials or items put forward for testing are indeed identical to those composing the PPE.









....... ....... 24/06/94 ....... 01/07/96


Clause :

Key words : type examination certificate, modification of products

Question : What should the manufacturer or his authorized representative established in the Community do in the case of a modification to a PPE model having been the subject of an EC type examination certificate?

Solution : The directive does not explicitly provide for the case of modification of a PPE model having been the subject of an EC type examination certificate. The manufacturer or his authorized representative established in the Community has to inform the notified body that delivered the EC type examination certificate of any intended modification of the PPE. The notified body then has to decide whether the modification does or does not require new type examination procedures. If the modification only involves minor changes not affecting the safety characteristics of the product, the notified body informs the applicant that the EC type examination certificate will continue to be valid for the modified mode. It may then either deliver a type examination certificate extension or a new certificate. If the modification consists of major changes to the product, the notified body has to inform the manufacturer or the authorized representative that the certificate cannot be transferred to the modified model. If the manufacturer intends to keep the modifications, he will be required to make a new official request for an EC type examination.









....... ....... 24/06/94 ....... 01/07/96


Clause :

Key words : identification of test samples

Question : What are the measures to be taken for the identification of tested models for any subsequent controlling inspection or expertises?

Solution : There must be no ambiguity regarding the identification of the PPE having been submitted as a type (model) to a notified body for EC type examination. PPE placed on the market are the subject of the tested type declaration of conformity. The following is recommeded: - the alphanumeric reference of the models must be provided by the manufacturer with an indication of its meeting - the photographs needed for correct identification of the PPE must accompany the certificate and a copy of these photographs must be

archived with the file by the notified body - an example of the PPE in a finished state can be archived by the notified body when this is possible - if this is not possible, representative samples will have to be stored.









....... ....... 31/05/96 ....... 01/07/96

Question related to : Directive 89/686/EEC EN/prEN : Other : Annex : Article : 11 A.1

Clause :

Key words : quality control, manufacturer

Question : Article 11 A of the directive refers to "a manufacturer", but who is "a manufacturer"?

Solution : Agreement that the manufacturer in this context must at least carry out the final assembly of the PPE. This is necessary due to the responsibility to ensure homogeneity of production, which can only be achieved through controlling the manufacturing process.









....... ....... 31/05/96 ....... 01/07/96


Clause :

Key words : quality control, checks

Question : At what frequency should the required "necessary checks" (as referred to in article 11 A) be carried out?

Solution : A minimum of one per year, the year starting from the date of issue of the certificate.









....... ....... 31/05/96 ....... 01/07/96


Clause :

Key words : quality control, application of CE marking

Question : Should the checks referred to in article 11 A.2 be carried out before the application of the CE marking or afterwards?

Solution : As a minimum the manufacturer must have entered into a formal agreement with a notified body for assessment against 11 A. This is explicit in article 12 of the directive, whereby the EC declaration is drawn up before the application of the CE marking and part of the declaration states which body is/will be supervising the 11 A procedure. The amending directive covering the application of the CE marking requires the number of the notified body responsible for administering article 11 to be added to the marking. It would appear sensible for notified bodies to have checked a company's control procedure before agreeing to its number being marked on the product.








Origin : Horizontal Committee, Article 11 ad hoc group Ad hoc group ........................ Horizontal Committee ........... Standing Committee .............

....... 21/11/2013 ....... 22/11/2013 .......01/10/2015


Clause :

Key words : 11A checks, time interval, random.

Question : What does "random" mean (in article 11 A.2)?

Solution : For on-site assessments and sampling, the interval between visits to be varied, and for remote sampling selection without the manufacturer's advance knowledge, where possible. Where samples are to be selected from distributors, warehouses etc. it will be necessary to arrange visits directly with the people concerned.









....... ....... 24/06/94 ....... 20/05/95


Clause :

Key words : CE marking, categories

Question : CE marking according to the directive 93/68/EEC does not provide for a clear distinction between categories I and II. Is it possible to amend the provisions on CE marking so as to include a distinction, as this is considered to be helpful to the user?

Solution : At the moment there is no intention to change the situation by another amending text.









....... ....... 27/05/98 ....... 20/04/98


Clause :

Key words : article 11 A , necessary checks

Question : What are the necessary checks required under article 11 A.2?

Solution : Each certified model to be selected by the notified body at least once per year. The notified body has an obligation to sample and test products that adequately represent the products within the family / group of products. The selected sample(s) must be checked for compliance with the type described in the EC type approval certificate and the relevant basic requirements of the directive. That means, the compliance with 11 A is checked by every model tested once a year, no assessment of the manufacturing process.








Origin : Horizontal Committee Article 11 Ad hoc group Ad hoc Group ........................ Horizontal Committee ........... Standing Committee .............

....... 21/11/2013 ....... 22/11/2013 ....... 01/10/2015

Question related to : Directive 89/686/EEC EN/prEN : Other : Annex : Article : 11 B

Clause :

Key words : Article 11 B, withdrawal of certificates

Question : What procedure should be followed in the event of failures during 11 B assessments?

Solution : In the event of failures in 11 B assessments, the notified body concerned has to decide in each individual case, taking into account the reasons that lead to the failure and the risks involved. In serious cases, e.g., major nonconformities issued against either the system or the product, the notified body should proceed to withdraw their 11B approval; in that case the Member State giving notification will have to be informed. NOTE: The failures can concern both quality system failures and product performance failures.









....... ....... 02/06/95 ....... 01/07/96


Clause :

Key words : manufacturer, authorized representative

Question : The directive always refers to the manufacturer or his authorized representative established in the Community. Can manufacturers worldwide act equivalent to companies in the Communnity?

Solution : The PPE group of the Standing Committee 89/392/EEC stated that the directive 89/686/EEC does not distinguish between the manufacturer's location inside or outside the EEA. Only (authorized) representatives need to be based in the EEA.









....... ....... 01/06/95 ....... 18/11/97

Question related to : Directive 89/686/EEC EN/prEN : Other : Annex : III Article : 10

Clause :

Key words : type examination: contents of technical file, technical documentation

Question : Which documents are part of the technical file / technical documentation mentioned in the directive? Annex III of the directive makes a distinction between the technical documentation, which has to be maintained by the manufacturer for submission to the authorities, if need be, and the technical file, which has to be submitted to the notified body in the framework of type examination. The description of the control and test facilities and the instructions of the manufacturer are part of the technical documentation, but not of the technical file. This means, however, that it is not possible for the notified body to assess the suitability of the test facilities or of the instructions of use during type examination. Recommended solution : It should be noted that there is no on-site assessment of the test equipment of the manufacturer under article 10 procedures. However, the description of the test equipment as well as the instructions for use are important for the assessment of the conformity of a product with the directive. Therefore, they have to be considered to be a part of the technical file.









....... ....... 24/01/2013 ....... 01/10/2015

Question related to : Directive 89/686/EEC EN/prEN : Other : Annex : II; 1.4 (e) Article :

Clause :

Key words : period of obsolescence

Question : There are a few items of PPE for which a definitive life can be stated. In general, the time for which an item of PPE can be used is dependent upon many and varied effects; for example storage, maintenance, conditions and frequency of use, etc. This presents a problem for manufacturers required to state a period and for notified bodies in assessing whether or not this requirement is complied with. A practical solution is required which satisfies the spirit of the Directive and supplies the necessary information to the user.

Recommended solution : All relevant information on the period of obsolescence and/or instructions to enable the user to assess and inspect the item to determine whether or not the item can continue to be used shall be given. Individual vertical groups may define more detailed specifications for different types of PPE. (see annex II, 2.4)









....... ....... 27/05/98 ....... 20/04/98

Question related to : Directive 89/686/EEC EN/prEN : Other : Annex : Article :

Clause :

Key words : components from different manufacturers

Question : Should a notified body agree to issue an EC Type Examination for a product submitted by manufacturer "A" which includes interchangeable components produced by a manufacturer "B" where the product requires to be tested as a complete device? for example: a) filters for an air powered device b) chemical protective clothing without a hood and/or boots c) helmet mounted ear muffs

Recommended solution : A notified body is responsible for reviewing the Technical Documentation for compliance with the relevant requirements of the Directive. Provided the client's documentation submitted covers all the applicable requirements the notified body may perform or arrange for the necessary tests to be carried out and if found satisfactory issue an EC Type Examination Certificate. Note: It is the manufacturer "A"'s responsibility to monitor that each subsequent product is in conformance with that tested for the EC

Type Examination and that the product manufactured by "B" remains the same and compatible with his tested product.









....... ....... 26/05/99 ....... 21/06/99


Clause :

Key words : marking, standard reference, testing according to prEN

Question : If only a prEN is available at the time of EC type approval, can the product be marked with the standard number „EN ...“? Where the EC type examination is issued against a prEN, can EN be marked on the product, once the standard is ratified?

Recommended solution : Marking with a standard reference is not mandatory by the directive.

Where a manufacturer decides to mark a standard or prEN on his product, the following principles apply: As long as no final standard exists or the final standard is not identical with the prEN, the marking cannot be "EN ...". If the ratified EN is identical to the prEN, then „EN ...“ may be marked on the product. Where the ratified EN is not identical to the prEN, then „EN ...“ cannot be marked on the product. Marking with a prEN is not recommended. However, where a manufacturer decides to mark with the prEN used for the EC type examination then it should be fully identified by year and/or issue.









....... ....... 04/06/97 ....... 20/04/98

Question related to : Directive 89/686/EEC EN/prEN : Other : Annex : Article : 11 A

Clause :

Key words : sampling 11 A procedures

Question : What sampling procedures are possible for 11 A procedures for small series of PPE, e.g. 10 PPE manufactured per year, especially if the tests are destructive tests?

Recommended solution : If the 11A option is taken, sufficient testing must be undertaken by the notified body. It is up to the notified body to decide how sampling could be done. If the manufacturer does not want to follow the 11A route, the only option is the quality system route 11B.






CNB/P/00.051 Revision 04 Language: E

Number of pages: 1 Date: 04.09.02


Origin : Horizontal Committee Vertical Group Horizontal Committee 23.02.00 Standing Committee 15.01.02

Question related to: Directive 89/686/EEC EN/prEN: Other: Annex: II, 1.4 Article:

Clause:

Key words: use of pictograms Question: Is it possible to mark a product with a pictogram described in an EN standard when the verification of essential requirements has been made against another EN standard or other technical specification ?

Solution: It is possible to use the pictogram even if the standard used is not the EN standard where the pictogram is described. The notified body, in reviewing the manufacturer’s instructions for use (information supplied by the manufacturer), must ensure that the meaning of the pictogram is clearly defined in respect of the essential health and safety requirements of the directive. NOTE: ‘Pictogram’ refers to the pictorial presentation; this does not include the EN number or performance levels. These must not be used if the EN is not the basis for testing.

Sent for information to: members of the VG other(s) VG HC (2) TC (3) SC (4) other (5)

(3): (5):








....... ....... 04/06/97 ....... 20/04/98


Clause :

Key words : test reports, designation of materials

Question : In test reports, materials are often only referred to by a single, mostly commercial reference name. In many cases, however, this name covers a variety of materials different by structure and weight (for fabrics) or by origin and thickness (for leather). Is it possible to have a uniform and clear "finger print designation" of materials in test reports in order to make an evaluation easier? For this purpose, we propose to use the elements as given below: - aramid twill 2/1 - 270 g/m² - cow split 1.3 - 1.5 mm. Recommended solution : A unique reference number or name identifying the material must be the same in the technical file and in the test report. The technical file should contain a documentation of the material, i. e. a sample or a proper identification.









....... ....... 04/06/97 ....... 20/04/98


Clause :

Key words : test reports, materials

Question : How old can test reports be when they are used for type examination?

Recommended solution : This is the responsibility of the notified body. The general view is that there should be no time limit for previous tests.









....... ....... ....... 18/11/97


Clause :

Key words : slip resistance, type examination certificate

Question : Does slip resistance have to be considered an essential requirement for safety, protective and occupational footwear?

Recommended solution : Slip resistance is a general feature of safety, protective and occupational footwear. Notified bodies have to carry out slip resistance testing, unless the manufacturer clearly claims in his product specification and in the user information that the footwear does not meet this requirement.









....... ....... 04/06/97 ....... 20/04/98


Clause :

Key words : type examination for category I PPE

Question : Could PPE which do not belong to categories II or III be submitted to an EC type examination on a voluntary basis?

Recommended solution : Only PPE belonging to categories II or III can be submitted to an EC type examination procedure leading to the issue of an EC type examination certificate.









....... ....... 26/05/99 ....... 21/06/99


Clause :

Key words : revision of standard, validity, EC type examination certificate

Question : When a new version of an EN standard is published, are manufacturers obliged to get their products tested to the new/revised version or can they continue to sell their product(s)?

Recommended solution : Current certificates remain valid. However, manufacturers have a responsibility to keep abreast of changes and to modify their products in the light of these changes to continue to supply safe products, which may necessitate the issue of a new certificate.









....... ....... 04/06/97 ....... 20/04/98

Question related to : Directive 89/686/EEC EN/prEN : Other : Annex : Article : 11A

Clause :

Key words : article 11A, change of certificate

Question : When controls carried out in accordance with article 11A give performance level classification figures, for example, lower than those stated in the EC type examination certification, should the original EC type examination certificate be changed?

Recommended solution : The EC type examination certificate cannot be altered, only withdrawn and a new one be issued to cover the new lower performance levels. The product in this case has to get a new identification. The procedure set out in the Directive should be followed. (Reference Article 11A, para 4 & 5)









....... ....... 04/06/97 ....... 20/04/98

Question related to : Directive 89/686/EEC EN/prEN : Other : Annex : Article : 10.2, 11 A, 11 B

Clause :

Key words : distribution, type examination certificate

Question : How should files concerning PPE likely to have several product identifications be processed?

Recommended solution : There are two acceptable situations. 1) The original manufacturer or his authorised representative remains responsible for placing the equipment on the market

The manufacturer is the certificate holder, and established the declarations of conformity. The technical construction file indicates the different forms of product identification and markings as well as the trade name of the distributors. The various versions of the instruction handbook are subject to EC type-examination (with the exception of direct translations into foreign languages).

2) The distributor or importer, acting as a manufacturer, is responsible for placing the equipment on the market Being responsible for placing the equipment on the market, the distributor / importer must request an EC type examination. The certificate or the extension to the certificate is established in the trade name of whoever is responsible for placing the equipment on the market. He, in turn, established the declarations of conformity in his name.







Number of pages: 1 Date: 26.10.06


Origin : Horizontal Committee Vertical Group Horizontal Committee 05.05.06 Standing Committee 31.07.06

Question related to: Directive 89/686/EEC EN/prEN: Other: Annex: II, 1.4 Article:

Clause:

Key words: information to users Question: What is the responsibility of the notified body in checking the information to users ?

Solution: The notified body shall verify that the equipment can be used in complete safety for its intended purpose (directive, article 10 (4) b). In order to do this, the notified body shall check that the claims of the manufacturer on the area and limits of protection of the product are in line with the technical specification used and with the relevant essential safety requirements. One of the essential safety requirements is to supply all relevant information as required by annex II, clauses 1.4, 2 and 3. The notified body must check that the information is given in accordance with these requirements and that it does not contain misleading statements and obvious mistakes concerning the protection provided. The manufacturer has the final responsibility for the accuracy of the content including translations. Note : Claims of compliance with standards other than harmonised European standards that have the same scope as those used as a

basis for type examination or claims that are not related to user protection, e.g. value for money etc., are the sole responsibility of the manufacturer.

Explanatory note: The Recommendation for Use was originally agreed in the Horizontal Committee on 23 May 2003. Confirmation

and re-submission to the PPE Expert Group on 5 May 2006.


(3): (5):








....... ....... ....... 18/11/97


Clause :

Key words : Production Plant

Question : Do certificates only cover PPE made at the production plant(s) specified either on the certificate or associated documents? If no, is the certificate holder free to sub-contract production to any alternative plant, without reference to the Notified Body, and apply the CE marking on the basis of the original certificate and declaration?

Recommended solution : The Type Examination certificate is linked directly to the production plant(s) specified at the time of application.

- Only products made at the specified site(s) are covered by the certificate and these can be CE marked following the drawing up of the necessary declaration.

- If alternative production plants are to be used, the Notified Body who issued the original certification must be informed. The N.B.

decides, in agreement with the manufacturer, what level of verification testing, if any, is required before amending the certificate and/or the technical file.







Number of pages : 1 Date :31/05/99 Approval by : Approved on :


....... ....... 27/05/98 ....... 21/06/99

Question related to : Directive 89/686/EEC EN/prEN : Other : Annex : Article : 1, 2 (c)

Clause :

Key words : interchangeable components, EC type examination

Question : Should interchangeable components be submitted to an EC type examination?

Recommended solution : Yes, an EC type examination certificate can be issued in accordance with Article 1;2 c. The notified body shall carry out sufficient evaluation and/or testing to verify their suitability for the stated equipment in its final assembly.







Number of pages: 1 Date: 21//11/2013


Origin :Horizontal Committee, Article 11 ad hoc group Ad hoc group 21/11/2013 Horizontal Committee 22/11/2013 Standing Committee 01/10/2015

Question related to: Directive 89/686/EEC EN/prEN: Other: Annex: Article: 11 B

Clause:

Key words: composition of audit team; competency of auditors; knowledge of auditors Question: How should the audit team be composed?

Solution: The audit team must include at least the following Experience and knowledge of the relevant quality system requirements (e.g. ISO 9001) and the product technology concerned. Knowledge of the type examination certificates which are applicable to the scope of the assessment. Access to and knowledge of the applicable Recommendation for Use sheets. Knowledge of the status of the standards applicable to the scope of the assessment (amendments, revisions, drafts, final drafts etc.). Note: The audit team can either be a single person with the required knowledge, skills etc., or a number of different people making up a team.


(5): EU Commission






Number of pages: 1 Date: 23/03/2010


Origin : Horizontal Committee, Article 11 ad hoc group Ad hoc group 21/11/2013 Horizontal Committee 22/11/2013 Standing Committee 01/10/2015

Question related to: EN/prEN: Other: Annex: Article:

Clause:

Key words: quality assurance system Question: Must existing certificates relating to QA-Systems (ISO 9001) be accepted by a notified body?

Solution: No; but the notified body is able to take into account existing certificates relating to QA-systems (ISO 9001) if it is convinced of the qualification of the certification body (accreditation, mutual recognition and others). In all cases the notified body must add product and regulation-related aspects.


(5): EU Commission







Origin : VG12 Certification of Quality Systems, article 11B HC ad-hoc committee

Vertical Group ....................... Horizontal Committee ........... Standing Committee .............

....... 29/11/95 ....... 05/01/98 ....... 20/04/98

Question related to : Directive 89/686/EEC EN/prEN : Other : Annex : Article : 11.B (2)

Clause :

Key words : Quality Assurance System, Supervision, Frequency of Audits

Question : What frequency of audits is necessary to fulfil the obligation arising from Article 11 B (2) of Directive 89/686/EEC?

Recommended solution : A supervision frequency of at least once a year. See also RfU no. 00.106.








Origin : VG12 Certification of Quality Systems, article 11B HC ad-hoc committee

Vertical Group ....................... Horizontal Committee ........... Standing Committee .............

....... 29/11/95 ....... 05/01/98 ....... 20/04/98

Question related to : Directive 89/686/EEC EN/prEN : Other : Annex : Article : 11.B (c)

Clause :

Key words :

Question : When must ISO 9001/2/3: 1994 be used as the harmonised standard?

Recommended solution : The certification and procedures, of notified bodies and manufacturers, which reference ISO 9001/2/3, must reference the 1994 version by the end of 1998, at the latest.








Origin : Horizontal Committee, Article 11 Ad hoc group Article 11 Ad hoc ................... Horizontal Committee ........... Standing Committee .............

....... 21/11/2013 ....... 22/11/2013 ....... 01/10/2015

Question related to : Directive 89/686/EEC EN/prEN : Other : Annex : Article : 11.B (b) / 11.A.3

Clause :

Key words :

Question : Must the "appropriate tests" be as specified in the product standard or product specification?

Recommended solution : The manufacturer's routine/regular inspections and tests can be supplemented by alternatives, providing that the manufacturer can prove there is sufficient correlation. Where this is the case, the compulsory test/inspection programme against the product standard/specification can be less frequent. Where alternative methods are used, they shall be described in the manufacturer’s quality system documented procedures.









....... ....... 26/05/99 ....... 21/06/99

Question related to : Directive 89/686/EEC EN/prEN : Other : Annex : II Article : 1.4 (i)

Clause :

Key words : notified body reference, information supplied by the manufacturer

Question : 1. Has information on the notified body who certifies a PPE product to be included in the user information? 2. What is the correct interpretation of the PPE Directive as amended?

Recommended solution : 1. Yes. Reference 93/68/EEC (Article 7, para. 7) which amends section 1.4 requiring „the name, address and identification number of

the notified body involved in the design stage of the PPE;“ 2. The details to be included in the manufacturer’s user information must be that of the notified body responsible for the issue of the EC

type examination. It should be noted that in some cases more than one notified body may be involved, i. e. combined PPE. In such cases the information supplied would be for each notified body involved.








Origin : Horizontal Committee Vertical Group ............

Documents

Horizontal Recommendation for Use sheets (RfUs) of the ... · 00.124 02 Directive 89/686/EEC Boil-and-bite mouth guards 03/12/05 30/06/05 00.125 05 Directive 89/686/EEC, Article 11.A